I’ve lamented time and time again how much woo has managed to infiltrate academic medicine, even to the point where prestigious medical schools such as Harvard and Yale have fallen under its sway. I’ve even gone so far as to lament that resistance is futile when it comes to the rising tide of woo threatening to wash over academic medicine, although lately I’ve been in a more pugnacious mood.
But what good is a pugnacious mood when denialist pseudoscience starts popping up credulously reported in news sources tailored for physicians and other health care professionals? That’s exactly what happened last week.
Like many physicians, I often peruse Medscape. It’s generally been a convenient and quick way to catch up on what’s going on in my field not directly related to my research, for which I tend to rely on pre-configured RSS feeds for PubMed searches to highlight any articles related to my areas of interest. Since these searches routinely flag hundreds of articles a week whose titles and abstracts I end up perusing, sometimes only cursorily to identify the articles I might want to read, it is impractical for me to rely on this approach for areas that are even only a bit out of my field. That’s where, at least so I thought, services like Medscape came in handy. I could look over stories and quickly find out about research and medical of interest to me, only occasionally needing to look up the actual journal articles. Like a fair number of physicians, I rely on it fairly regularly. I should also point out that Medscape sometimes even tries to go against the tide of woo, as it did when it published an article by Kimball C. Atwood IV, MD; Elizabeth Woeckner, AB, MA; Robert S. Baratz, MD, DDS, PhD; and Wallace I. Sampson, MD, entitled Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned, a tour de force deconstruction of why TACT is bad science and unethical to boot.
So how to explain an article by Alison Gandey entitled HPV Vaccine Adverse Events Worrisome Says Key Investigator?
The article could have been a fair assessment of whether the risks of Gardasil are higher than reported. “Could have” is the operative phrase. Unfortunately, in among the real scientists, Gandey parroted back a whole lot of antivaccination nonsense and a misunderstanding of the VAERS database. For example, there was this howler:
Members of the antivaccine movement point to a number of potential perils, including the presence of aluminum in injections. Like many vaccines, Gardasil contains aluminum salts. Each 0.5-mL dose contains approximately 225 μg of aluminum, 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 μcg of polysorbate 80, 35 μg of sodium borate, and water.
Oh, no! Toxins!
I’m really terrified of that sodium chloride, but what about that horrific L-histidine? Oh my God! We’re poisoning the children! I suppose I should be grateful that Gandey refrained from mentioning formaldehyde, antifreeze, or the ever-dreaded fetal parts gambit, but, then really, she came very close. On the other hand, anti-vaccine advocates know the significance of mentioning borate (it’s a “roach killer,” you know) or polysorbate 80, (it’s been linked to infertility in mice, supposedly). Remember my old “toxins” post, and you’ll see how ridiculous these gambits are. (For example, the rat study of the effects of polysorbate 80 injected rats with amounts of the chemical that, by body weight, were incredibly high; nowhere near that amount is found in vaccines. By the way, histidine is an amino acid that’s found in virtually every protein in the body. It’s also an essential amino acid in growing children. That Gandey would even mention it along with aluminum and other ingredients in the context of antivaccinationists’ complaints about a “number of perils” shows truly awful judgment. As for aluminum, as I’ve said many times before, now that mercury in vaccines is being increasingly exonerated as a cause or “trigger” for autism by multiple studies and lots of science, to antivaccinationists aluminum is the new mercury. Yet, aluminum salts used as adjuvants have an 80 year track record of safety in vaccines, nor is there any compelling evidence, as claimed by antivaccinationists, that it causes or contributes to Alzheimer’s disease.
Next, Gandey quotes Christiane Northrup, MD. Yes, that Christiane Northrup, Oprah Winfrey’s favorite gynecologist and regular guest on her show, the one who has on Oprah’s show discussed how women should use use qi gong to direct women’s qi into their vaginas in order to have more powerful orgasms. Truly, you just can’t make stuff like this up. (At least, I can’t.) Harriet Hall, MD, otherwise known as the SkepDoc (a title I should have snagged back when I started this blog, actually, assuming she didn’t yet have it then) has deconstructed Dr. Northrup’s ideas, which, much like Andrew Weil‘s, are a mix of the sensible and science-based buried in a heapin’ helpin’ of big time woo. For instance, Dr. Northrup is an advocate of so-called “bioidentical hormones,” the dubiousness of which I’ve discussed before. Two words: Suzanne Somers. That should tell you all you need to know about so-called “bioidentical” hormones, as should Dr. Hall’s discussion a while back.
Dr. Northrup serves up a heapin’ helpin’ of stupid, too. I kid you not Indeed, she regurgitates standard tropes of germ theory denialists. Yes, germ theory denialists. You may ask how on earth in the year 2008 anyone can doubt the germ theory of disease anymore, given how much evidence supports it. Think of it this way: In 2008 there are still people who believe that evolution is not a valid theory and that the earth was created 4,000 years ago over the course of six days. In any case, here’s what Dr. Northrup said:
Dr. Northrup recommended that the money going toward vaccines and related programs be allocated to general health and wellness initiatives and proper nutrition. This harkens back to the age-old debate between Louis Pasteur and Antoine Beauchamp, Dr. Northrup suggests.
For most of his career, Pasteur subscribed to germ theory, while Beauchamp backed the more unpopular theory of biological terrain. The question: Is it the germs themselves that make people sick or a weakened state of immunity that allows germs to take root? “Pasteur was widely supported, but on his death bed conceded that Beauchamp was right,” Dr. Northrup said during an interview. She suggests that this is what experts should be concentrating on now.
Here’s the problem. None of the above is true, other than that there was a debate between Pasteur and Beauchamps in the late 1800s over “seed versus soil” when it came to whether or not microbes could cause disease. That debate was settled long ago–and not in Beauchamps’ favor, for the most part. Indeed, it is nothing more than a myth promulgated by germ theory denialists that Pasteur “recanted” germ theory on his deathbed or admitted that “Beauchamps was right” after all. Northrup is either lying or simply too clueless to have checked into this myth, the same myth that has been routinely parroted by credulous idiots like Bill Maher. And Gandey serves up this quote without even bothering to check whether what Dr. Northrup said was, in fact, true. It’s lame reporting at its worst, because a quote like this should have set her skeptical antennae twitching.
Except that apparently Gandey doesn’t have any skeptical antennae.
Finally, Gandey fails to give any sort of context for the reports of 9,700 adverse reactions reported to the Vaccine Adverse Event Reporting System (VAERS). What people don’t understand about VAERS is that it’s not a good epidemiological for establishing strong evidence of causation, and it’s dubious even for correlation. Indeed, such was never its intent when it was designed. VAERS was originally intended as a “canary in the coalmine,” so to speak, in that anyone can report problems that occur in close temporal proximity to vaccines. It’s an early warning system, not a rigorously administered database. “Adverse events” reported don’t even have to be something that looks suspicious as having been caused by vaccines. Indeed, there is the infamous story of how Dr. Jim Laidler once reported to VAERS a most unusual complication from vaccination:
The chief problem with the VAERS data is that reports can be entered by anyone and are not routinely verified. To demonstrate this, a few years ago I entered a report that an influenza vaccine had turned me into The Hulk. The report was accepted and entered into the database.
Because the reported adverse event was so… unusual, a representative of VAERS contacted me. After a discussion of the VAERS database and its limitations, they asked for my permission to delete the record, which I granted. If I had not agreed, the record would be there still, showing that any claim can become part of the database, no matter how outrageous or improbable.
In other words, just because a health problem or event is reported to VAERS does not mean that it was related to any vaccine. Moreover, whenever a reporter writes about VAERS, he or she should be aware that VAERS is very susceptible to corruption by publicity, well-meaning advocacy groups, or even litigation in a way that no other vaccine database is. As Dr. Laidler put it:
Since at least 1998 (and possibly earlier), a number of autism advocacy groups have, with all the best intentions, encouraged people to report their autistic children–or autistic children of relatives and friends–to VAERS as injuries from thimerosal-containing vaccines. This has irrevocably tainted the VAERS database with duplicate and spurious reports.
It’s even worse than that, though. As was shown in a study by Michael J. Goodman and James Nordin published in the journal Pediatrics in 2006, vaccine litigation has hopelessly corrupted the VAERS database. This is how I summarized the study when it came out:
In the study, the authors, did something incredibly simple that no one had done before. They took data from the VAERS database from 1990 through 2003 and imported it into SAS data files for analysis. Then they searched the database using key words to look for reports associated with litigation, particularly with regards to autism. They searched for records containing “thimerosal,” “mercury,” or “autism” in their fields, especially when coupled with terms like “lawyer,” “legal,” “attorney,” or “litigate,” while excluding records containing “legal” coupled with the term “guardian” that did not relate to litigation. They also excluded cases related to well characterized allergic reactions to thimerosal. Finally, they compared records from nonlitigation cases to those from litigation cases regarding symptomatology reported.
Not surprisingly, beginning in 2001, they noted a dramatic increase in the number of non-Lyme disease VAERS reports related to litigation, from only 7 in 2000 to 213 in 2002 and 108 in 2003. (They attributed the decline in 2003 reports to processing delays in creating public use files.) Next, they examined reports related to symptom sets. For autism, they observed a dramatic increase in the percentage of litigation-related reports from 0% of the reports related to litigation in 1999 to over one-third (35%) in 2002. For records mentioning thimerosal that weren’t related to allergic reactions, the rise was even more dramatic, from 0% of these reports related to litigation in 2000 to 87% in 2002.
I have to wonder whether anti-vaccine advocacy groups, religious groups opposed to Gardasil on the grounds that it will “encourage promiscuity,” or potential litigants are doing something similar with Gardasil. There’s no way of knowing yet because Gardasil is too new and there hasn’t been sufficient time to look at such trends and correlations in VAERS. In any case, the ease with which the VAERS database can be influenced by publicity, advocacy, and litigation-driven reports is what makes it virtually useless for longitudinal studies or studies of correlation (and also a reason why it is so beloved of antivaccine cranks like Mark and David Geier, who love to go data mining in it for spurious correlations between vaccines and autism). The CDC’s Vaccine Safety Datalink (VSD) is a much better resource for doing epidemiological studies about whether vaccines cause or contribute to specific adverse events or complications.
Now, let’s take a closer look at those reported adverse events, shall we? The reason, of course, is that it’s not just Medscape that discusses these alarming-sounding VAERS reports without context. CNN has the same thing recently, too, but I expect more of Medscape. Unfortunately, this time, I didn’t get it. Indeed, Medscape appears to have done even worse a job than CNN. For example, when Medscape reports that 6% of the adverse events reported to VAERS were considered “serious,” as it turns out, this is less than half the 15% of reactions reported as “serious” for other vaccines. Moreover, although there is a mention that it’s impossible to tell whether these events were related to vaccines or not, the overall impression left by the article is that there’s a strong reason to be concerned. This impression is given by the relatively free rein given to opponents, even to the point of reporting nonsense spouted by Dr. Northrup, and the relatively little said by those supporting the safety of vaccines, as well as by the anecdote of a possible adverse reaction reported in the article. It’s also bolstered by the lack of anything resembling a serious discussion of why VAERS reports are very poor evidence for adverse events causation by a vaccine. Whether this is due to Merck being reluctant to emphasize this to a reporter who is clearly looking for a story about “covered up” risks, I don’t know. Maybe the Gardasil “skeptics” gave better sound bites.
Left out for the most part was information to put these reports in context. For example, here’s what the American Cancer Society says about the possible link between Gardasil and Guillain-Barré syndrome or death:
There have been 15 reports of sudden death after vaccination. The CDC says after careful review of the 10 reports that had adequate information for analysis, CDC could not establish the causal relationship between vaccination and death.
In addition, there had been 31 reports of Guillain-Barré Syndrome (GBS) after Gardasil vaccination in the U.S, ten of which had been confirmed as GBS. Of those 10, 5 reported vaccination with Menactra, a vaccine against meningitis, at the same time. Of the remaining 21 reports, 7 did not meet the case definition for GBS, one had symptoms of GBS prior to vaccination, 4 were unconfirmed reports, and 9 were pending additional follow-up. The CDC says the number of GBS cases reported are within the range that could be expected to occur by chance alone after a vaccination. CDC and FDA physicians and scientists continue to review all reports of serious side effects reported to VAERS to identify potential new vaccine safety concerns that may need further study. The American Cancer Society continues to monitor those reviews to ensure the safety of those who receive the vaccine, which has the potential to prevent the majority of the cases and deaths of cervical cancer.
Funny that none of this was mentioned in the Medscape article. Where Gandey went wrong as well was in emphasizing doubts about the vaccine’s effectiveness above all else, whether valid concerns or not. For instance, she reported this quote:
At the 2006 American Society of Clinical Oncology annual meeting, delegates were enthusiastic. One presenter showed a series of cervical cancer photos and told observers that “these types of pictures will soon disappear in clinical oncology.”
Unfortunately, that utopian prediction is unlikely. “Cervical cancer is not a vaccine-preventable disease,” Dr. Lippman said during an interview. And in her recent editorial, she points out that surrogate end points — not cervical cancer — were used to measure the efficacy in the clinical trials.
“No one would want to wait to see cervical cancer develop in participants,” she writes. “But the general failure to mention that the precancerous lesions chosen for study are not only potentially removable, most (those that are CIN 2) would probably have resolved on their own without any intervention, is arguable.”
By this rationale, the MMR vaccine does not prevent subacute sclerosing panencephalitis (SSPE), a rare but late complication of measles, and the influenza vaccine does not prevent flu-associated pneumonia. I realize that some advocates of the HPV vaccine sometimes have a distressing tendency to oversell its benefits or label everyone questioning whether it is ready for widespread use yet as ““anti-woman,” but it’s a mistake to go too far the other way and undersell its benefits as well. There’s also a difference between saying that a vaccine against HPV can prevent cervical cancer, which is what is claimed based on the data, and saying it’s a “cervical cancer vaccine,” which strikes me as a bit of a straw man characterization of what advocates of HPV vaccination actually do say about it. One other argument presented against the vaccine also strikes me as a bit disingenuous:
Dr. Makhija noted that the bulk of the work to date has focused on just 2 types of HPV — 16 and 18. She added that, going forward, more virulent cancer-causing strains could emerge, making it difficult to eliminate disease.
Well, yes, but vaccinating against any virus or bacteria might allow more virulent strains to emerge, too. That’s not a reason not to give a vaccine, if that vaccine is safe and effective.
In conclusion, let me just point out that, as one of the main resident vaccine advocates here on ScienceBlogs, even I am not yet convinced entirely that state-recommended and state-funded mass vaccination programs with Gardasil or any other HPV vaccine are, at this stage, warranted. The reason is not so much that I am concerned that the vaccine is not safe or that it is not effective, but rather lies in the context of the entire vaccination program taken as a whole. One problem is the expense of Gardasil. Compared to other vaccines that protect against acute deadly diseases, it’s not cheap. Second, my concern lies in whether the evidence is such that the vaccine’s benefits outweigh its expense and risks by a margin comparable to that of other vaccines in the routine childhood vaccination schedule, which is what I consider a necessary burden of proof to be met before the vaccine is added as a routine part of the overall vaccination schedule.
That being said, Medscape is supposed to be operating at a higher plane, scientifically speaking, than mainstream news outlets. It failed miserably in its responsibility by publishing this misinformation-laden and biased article that even went so far as to allow the parroting of germ theory denialism by someone as unqualified as Dr. Northrup. The debate over whether the HPV vaccine should become a regular part of the routine health care of girls in this country is an important one, and articles such as this serve only to confuse, rather than enlighten. It’s not as bad as some reporting of human interest stories in which a claim that a health problem is related to vaccines is quite astoundingly dubious, but it’s of the same ilk. Personally, I’m of the belief that HPV vaccination is safe and probably a good idea, but I haven’t yet been convinced that a mass vaccination program is yet justified. I’m close, but I”m not quite there yet, and I don’t claim that some skepticism isn’t warranted. The problem is that skepticism demands accurate information about potential risks and benefits, and this Medscape article provided neither.
I guess I now know that I should be a lot more skeptical of anything published on Medscape. Fool me once, shame on you. Fool me twice, shame on me.